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한약에 대한 N-of-1 임상시험의 현황 ? 문헌 고찰

Current Status of N-of-1 Trials for Herbal Medicine -Literature Review

대한한의학회지 2020년 41권 1호 p.107 ~ 116
정창운 ( Jeung Chang-Woon ) - 청연중앙연구소

전선우 ( Jeon Sun-Woo ) - 청연중앙연구소
조희근 ( Jo Hee-Geun ) - 청연중앙연구소

Abstract


Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine.

Methods: A systematic literature review was conducted based on the pubmed database. The search term were ‘N-of-1 Trial’, ‘Chinese Medicine’, ‘Herbal Medicine’, ‘Kampo’. There was no restriction in year.

Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication.

Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

키워드

N-of-1; Single Case Studies; Clinical Trial; Herbal Medicine; Korean medicine
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